Status:
COMPLETED
Effects of Palmitoylethanolamide on Inner Retinal Function in Glaucoma Patients by Pattern Electroretinogram
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The general purpose of the study is to evaluate the potential beneficial effects of PEA 600 mg supplementation on RGCs function in subjects with glaucoma by pattern electroretinogram after three month...
Detailed Description
Monocentric, randomized, prospective, single blind, two treatment and two period crossover study. The investigators have proposed a cross-over trial to avoid or to detect the bias due to intra-indivi...
Eligibility Criteria
Inclusion
- -age 18 years or older
- diagnosis of primary open angle glaucoma (POAG)
- controlled IOP (\<18 mmHg, morning value) with any topical lowering medication (beta-blockers, carbonic anhidrase inhibitors, alpha2agonists, prostaglandin analogues as monotherapy or as associative therapy; betablocker/carbonic anhydrase inhibitor, betablocker/alpha2agonist, prostaglandine/betablocker and alpha2agonist/carbonic anhidrase inhibitor fixed combinations as monotherapy or in association);
- stable IOP\<18 mmHg in the last 2 years
- stable disease in the last 2 years (no more than -1 deciBell-dB/year at MD of visual field)
- at least two reliable visual fields per year in the last 2 years
- no filtering surgery or other ocular surgery in the preceding 6 months
- written consent to participate to study procedures and data utilization in an anonymous form
Exclusion
- ocular hypertension with normal optic nerve and visual field
- contraindication to PEA
- glaucomatous scotomas within 10 degree from fixation
- any condition limiting the patient's ability to participate in the study;
- other causes of visual field changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion
Key Trial Info
Start Date :
March 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04088084
Start Date
March 9 2015
End Date
December 31 2017
Last Update
September 12 2019
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